FDA.report

heat it for Android

Primary DI
04262370293116
Brand
heat it for Android
Company
Kamedi GmbH
Model
00003AN
Device description
Smartphone add-on for the symptomatic treatment of insect bites with heat.
Published
2022-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IRTPad, Heating, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04262370293116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04262370293116042623702931164262370293116

GMDN Terms

TermDefinition
Insect bite/sting hyperthermia deviceA portable, electrically-powered device intended to be used for the external surface treatment of insect bites or stings (e.g., from midges/gnats, mosquitoes, wasps, hornets, horseflies) through the topical application of concentrated heat. The heat (around 50° Celsius) works to minimize or prevent itching, and may prevent subsequent swelling. It may be either a self-contained hand-held unit or an attachment for a smartphone. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
315161593
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04262370293017heat it pro USB-C010_00577-22024-04-23
04262370293031heat it classic USB-C010_00575-42024-04-23
04262370293062heat it pro Lightning010_00577-32024-04-23
04262370293086heat it classic Lightning010_00575-52024-04-23
04262370293123heat it for iPhone00003IN2022-09-13

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